Drug Recall
Terminated
Historical recordClass II
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiated
- August 17, 2023
- Reported by FDA
- September 6, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
by TMC Acquisitions LLC dba Tailor Made Compounding
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- August 15, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
by TMC Acquisitions LLC dba Tailor Made Compounding
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- August 15, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide within the USA
View recall →
Drug Recall
Ongoing
Historical recordClass II
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
by Inmar Supply Chain Solutions, LLC
- Reason
- CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
- Recall initiated
- August 14, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
View recall →
Drug Recall
Completed
Historical recordClass III
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
by Baxter Healthcare Corporation
- Reason
- Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- Recall initiated
- August 14, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide in the U.S.A.
View recall →
Drug Recall
Completed
Historical recordClass II
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiated
- August 9, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Completed
Historical recordClass II
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiated
- August 9, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Completed
Historical recordClass II
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiated
- August 9, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Completed
Historical recordClass II
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiated
- August 9, 2023
- Reported by FDA
- August 30, 2023
- Distribution
- Nationwide in the USA
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
